Artemether is an antimalarial API and pharmaceutical preparation. It is chemically sensitive to light, temperature and oxygen. The key storage requirements are light protection, airtight sealing, temperature control and moisture prevention. Details are specified in general requirements, environment, containers, stacking and special management as follows:
ⅠBasic Storage Conditions
Temperature control Store in a cool place at a temperature not exceeding 20°C. Certain injections and oily preparations shall be kept in a cold place at 2–8°C. Freezing and exposure to intense heat and sunlight are strictly prohibited. High temperature may cause degradation of active ingredients, reduction of assay content and increase of related impurities.
Strict light protection This product is prone to oxidative decomposition when exposed to light. It must be stored in a dark warehouse or light-proof containers, kept away from windows, spotlights and ultraviolet lamps. Outdoor storage is forbidden.
Moisture and odor prevention Keep in a dry environment with relative humidity of 45%–75% in the warehouse. Place away from damp floors and water sources, as well as areas with volatile acids, alkalis, pesticides and chemicals to avoid odor absorption and cross-contamination.
ⅡPackaging and Sealing Requirements
Keep the original packaging intact and tightly sealed. Open storage is not allowed. Solid raw materials are generally packed in aluminum foil bags, light-proof plastic drums or amber glass bottles. All liquid preparations shall be filled in amber light-shielded bottles.
Reseal immediately after sampling or use to minimize exposure to air and prevent oxidative deterioration.
III. Warehouse and Stacking Management
Store in separate designated areas. Pallets and shelves shall be placed no less than 10 cm above the ground and 30 cm away from walls, ceilings and air vents. Ensure adequate ventilation.
Mixed storage prohibited Do not store together with oxidants, strong acids, strong alkalis, flammable substances or toxic materials. Keep apart from food and daily necessities.
Arrange goods neatly. Avoid extrusion and impact to prevent package damage, powder or liquid leakage.
Ⅳ Safety and Shelf Life Management
Most preparations are oily solutions. Keep away from fire and heat sources. Open flames are forbidden in the warehouse, and fire prevention measures shall be properly implemented.
Adhere to the first-in, first-out principle and conduct regular inspections. Check for appearance abnormalities including discoloration, turbidity, precipitation, leakage and caking. Isolate defective products for re-inspection promptly.
Manage products strictly in accordance with expiry dates. Mark expired and deteriorated goods separately and dispose of them through compliant procedures.
ⅤAdditional Requirements for Preparations
Artemether Injection / Oily Solution: Besides cold and dark storage, avoid severe shaking during transportation and storage to prevent delamination of the emulsion.
Oral Preparations: Prioritize moisture proofing to prevent tablet splitting and softening of capsule shells caused by dampness.
VI. Temporary Storage During Transit
Maintain light shielding and temperature control during short-distance transportation. Avoid prolonged exposure to direct sunlight inside closed vehicles in summer. Follow the above temperature and humidity standards for temporary storage at transit points.
